Clearance Summary
MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05 received FDA 510(k) clearance under submission number K071960, sponsored by Meditech Kft.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2007-08-03.
- Submission: K071960
- Applicant / Sponsor: Meditech Kft.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2007-08-03
Classification & Regulation
This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.